About the Role A global biopharma organisation is growing its Devices Centre of Excellence in Cambridge, UK and is looking for a Quality Engineer (Compliance) to support medical device and drug–device combination product programmes across the product lifecycle from early development through to clinical and commercial supply. This is a hands-on, collaborative role for someone who enjoys being close to the development teams, keeping work audit-ready, and ensuring design control and risk management activities meet internal and global regulatory standards Key Responsibilities You’ll act as a quality SME for device and combination product development, with responsibilities including: * Leading design control and risk management activities for assigned programmes, ensuring deliverables are accurate, approved and maintained. * Supporting and facilitating risk management with external design and manufacturing partners. * Ensuring compliance with key standards and regulations including ISO 13485, ISO 14971, 21 CFR 820, EU MDR (and related internal procedures). * Providing input into design validation activities, including Human Factors Engineering / usability assessments. * Assessing suppliers and external partners for QMS capability, compliance and readiness. * Supporting investigations into device issues arising from clinical trials and commercial manufact...